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Starting soon Phase 2

Peiyuan Guben Tongluo Ointment for Elderly Sarcopenia

NCT07538674 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2026-04
Last updated
2026-04-20

Condition(s) studied

Sarcopenia in Elderly

Investigational drug(s) / intervention(s)

nutritional interventionExercisePeiyuan Guben Tongluo Ointment (Ejiao concentrated)Peiyuan Guben Tongluo Ointment (Agarose concentrated)

nutritional intervention: Provide protein and vitamin D supplementation.

Exercise: Receive standardized Baduanjin training with unified movements; the training is conducted 3 times weekly, starting 3 hours after meals, with a duration of 30 minutes per session.

Peiyuan Guben Tongluo Ointment (Ejiao concentrated): Peiyuan Guben Tongluo Ointment (Ejiao concentrated): 20 g once daily, administered with warm water; Composition: Rehmanniae Radix Preparata 120 g, Rehmanniae Radix 120 g, Epimedii Folium 60 g, Achyranthis Bidentatae Radix 120 g, Eucommiae Cortex 60 g, Dipsaci Radix 90 g, Astragali Radix 150 g, Codonopsis Radix 150 g, Dioscoreae Rhizoma 150 g, Paeoniae Radix Alba (stir-fried) 120 g, Polygonati Odorati Rhizoma 100 g, Scrophulariae Radix 90 g, Ligustri Lucidi Fructus 100 g, Ecliptae Herba 100 g, Citri Reticulatae Pericarpium 90 g, Atractylodis Macrocephalae Rhizoma (stir-fried) 150 g, Aucklandiae Radix 30 g, Salviae Miltiorrhizae Radix et Rhizoma 120 g, Chuanxiong Rhizoma 60 g, Sedii Aizi Herba 120 g, Anemarrhenae Rhizoma 90 g; Excipients: Agarose 450 g, Xylitol 45 g. Excipients: Tortoise Shell Glue 150 g, Deer Horn Glue 150 g, Ejiao 150 g, Xylitol 45 g.

Peiyuan Guben Tongluo Ointment (Agarose concentrated): Peiyuan Guben Tongluo Ointment (Agarose concentrated): 20 g once daily, administered with warm water; Composition: Rehmanniae Radix Preparata 120 g, Rehmanniae Radix 120 g, Epimedii Folium 60 g, Achyranthis Bidentatae Radix 120 g, Eucommiae Cortex 60 g, Dipsaci Radix 90 g, Astragali Radix 150 g, Codonopsis Radix 150 g, Dioscoreae Rhizoma 150 g, Paeoniae Radix Alba (stir-fried) 120 g, Polygonati Odorati Rhizoma 100 g, Scrophulariae Radix 90 g, Ligustri Lucidi Fructus 100 g, Ecliptae Herba 100 g, Citri Reticulatae Pericarpium 90 g, Atractylodis Macrocephalae Rhizoma (stir-fried) 150 g, Aucklandiae Radix 30 g, Salviae Miltiorrhizae Radix et Rhizoma 120 g, Chuanxiong Rhizoma 60 g, Sedii Aizi Herba 120 g, Anemarrhenae Rhizoma 90 g; Excipients: Agarose 450 g, Xylitol 45 g.

Study summary

With the agarose concentrating group of Peiyuan Guben Tongluo Ointment set as the parallel control and an external control established simultaneously, this study aimed to evaluate the increases from baseline in DXA-measured limb muscle mass after 12 weeks of medication in elderly sarcopenia patients treated with the Ejiao concentrating group of Peiyuan Guben Tongluo Ointment.

Eligibility

Sex
ALL
Min age
60 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients aged ≥ 60 years and ≤ 80 years, regardless of gender; ② Patients meeting the diagnostic criteria for sarcopenia in the elderly according to both traditional Chinese medicine (TCM) and Western medicine; * Patients meeting the TCM diagnostic criteria for Spleen-Kidney Deficiency Syndrome; * Able to take oral medications, willing to comply with the study intervention protocol, able to attend follow-up visits on time, and have signed the informed consent form. Exclusion Criteria: * Patients with quadriplegia, long-term bedridden status, zero muscle strength due to severe cerebrovascular accident, muscle atrophy caused by various factors, or inability to perform activities of daily living; * Patients with unclear consciousness, aphasia, delirium, inability to respond, or impaired time, location and orientation due to senile or vascular dementia; * Patients with severe mental illness, depressive state, or receiving relevant psychotropic medication; ④ Patients complicated with tumors, severe infections, gastrointestinal bleeding, hepatic and renal insufficiency, cardiac insufficiency, or other diseases affecting nutritional status; ⑤ Patients with hypersensitivity to the study drugs; patients who have received or are receiving traditional Chinese medicine treatment within the past 1 month; patients who have received medications affecting muscle contraction/relaxation within the past 1 month.

Primary outcome measure(s)

  • DXA-measured appendicular skeletal muscle mass — Baseline, week 12, week 24
    Detected by dual-energy X-ray absorptiometry (GE Healthcare, DXA). The skeletal muscle mass index (SMI) is defined as the ratio of DXA-measured skeletal muscle mass to the square of height.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Yueyang Integrated Medicine Hospital Shanghai Shanghai Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07538674 on ClinicalTrials.gov ↗ ← All trials in China